ISRCTN79173829已完成1 期
A two-part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple applications of the F11/25 transdermal patch formulation of hyoscine and physostigmine in healthy male participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Ability to give written informed consent prior to study participation
- •2. Healthy Caucasian male participants aged between 18 and 45 years (inclusive)
- •3. Body Mass Index (BMI) within the range of = 21 and = 30 kg/m2
- •4. Vital signs within the following ranges:
- •4.1. Pulse rate 40-90 bpm
- •4.2. Systolic blood pressure 90-140 mmHg
- •4.3. Diastolic blood pressure 50-90 mmHg
- •5. Ability to communicate well with the Investigator and to comply with the requirements of the study.
排除标准
- •1. Presence of any clinically-significant medical condition as determined by the investigator
- •2. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug (e.g. renal or liver disease, respiratory, immunological, endocrine or neurological disorders)
- •3. Any ECG abnormality other than sinus bradycardia or respiratory sinus arrhythmia
- •4. Known or suspected hypersensitivity or idiosyncratic reaction related to any of the study products
- •5. Any history of contact dermatitis
- •6. A dibucaine number of less than 70
- •7. Any skin disorder, broken skin, scars, tattoos at the sites of patch application (i.e. on both arms)
- •8. Glaucoma or a history of glaucoma in first-degree relatives (i.e. parents, siblings or offspring)
- •9. Presence of Anterior Chamber Narrow Angle (Van Herrick Grade 1 and 2)
- •10. Intra-ocular pressure exceeding 20 mm Hg
- •11. Uncorrected vision in both eyes of worse than 6/9 on the Snellen Scale
- •12. Corrected vision of 6/9 or better on the Snellen Scale when wearing +2.25 dioptre reading glasses
- •13. Requires glasses or contact lenses for distance vision
- •14. History of asthma (within the previous 10 years), exercise-induced bronchospasm or relevant seasonal bronchospasm
- •15. Lung function of less than 80% of predicted FEV1 and FVC values
- •16. History or evidence of drug abuse (opiates, methadone, cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates)
- •17. Positive test for HIV, Hepatitis B surface antigen or Hepatitis C antibody
- •18. History or evidence of alcohol abuse defined as an intake of more than 28 units per week (where 1 unit corresponds to 250 ml beer, 20 ml spirits/liqueur or one glass (100 ml) of wine)
- •19. Positive urine test for alcohol
- •20. Participation in another clinical study within the last three months
- •21. Use of any prescription medication within the last 14 days
- •22. Use of non-prescription medication within the last 7 days (apart from paracetamol)
- •23. Donation of blood or blood products within the last 3 months, or the intention to donate blood or blood products within 3 months after completion of the study
- •1. Development of any exclusion criteria since screening
- •2. Positive urine test for alcohol
- •3. Positive drugs of abuse test
- •4. Use of any prescription medication since screening
- •5. Use of non-prescription medication may impact the safety aspects and objectives of the study, within the last 7 days (apart from paracetamol)
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